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Tinto IgG, BSB-40, MMab

EUDAMEDFDA UDI

Class IVD General (EU MDR)

Ref BSB 5674

by Bio SB Inc

Identity

Trade Name
Tinto IgG, BSB-40, MMab EUDAMED
Tinto IgG MMab FDA UDI
Generic Name
Total immunoglobulin G (IgG total) IVD, antibody FDA UDI
Device Name
Tinto IgG, BSB-40, MMab EUDAMED
IgG antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in Phosphate Buffered Saline, pH 7.6, with protein base, and preserved with Sodium Azide preservative. FDA UDI
Model / Reference
BSB 5674 EUDAMED
Predilute, 7 ml FDA UDI
Description
IgG antibody is the purified immunoglobulin fraction of rabbit antiserum, diluted in Phosphate Buffered Saline, pH 7.6, with protein base, and preserved with Sodium Azide preservative. FDA UDI

Identifiers

Catalog Number
BSB 5674 FDA UDI
Primary DI / UDI-DI
B502BSB56740 EUDAMEDFDA UDI
Basic UDI-DI
B-B502BSB56740 EUDAMED
FDA Product Code
NJT FDA UDI
EMDN Code
W01030709 PRIMARY ANTISERA FOR IMMUNOHISTOLOGY EUDAMED
GMDN Term
Total immunoglobulin G (IgG total) IVD, antibody FDA UDI

Classification

Device Class
Class IVD General EUDAMED
Class I FDA UDI
Regulation Number
864.1860 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

New Device

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Tinto IgG, BSB-40, MMab by Bio Sb, Inc. — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/IVDD

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bio SB Inc
EUDAMED SRN
US-MF-000036462
Authorised Representative
QAdvis EAR AB SE-AR-000001599

Sources (2)

  • EUDAMED 157f51e5-1935-44b4-8a06-33e135d46ea8 61 fields · synced Jul 30, 2026
  • FDA UDI 3d82d77c-f55c-450c-a3bc-13d6fd4cff16 34 fields · synced May 30, 2026